Dysgnate afwijking Dysgnatic malformation over/underbite
Conditions
Interventions
The intervention in this study is an osteotomy of the upper and lower jaw
(bimaxillary osteotomy), performed using patient specific drill- and saw guides
and patient specific osteosynthesis of the m
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient is awaiting orthognathic surgical treatment, namely: bimaxillary osteotomies (upper and lower jaw) as part of their treatment plan; • The patient is at least 18 years of age. Completion of physical growth is a routine criterion for orthognathic surgery;
Exclusion criteria
Exclusion criteria: • Patient does not agree to randomized application of osteosynthesis method; • Pregnancy, which is a general contraindication for orthognathic surgery; • Known allergy to titanium • Patient is, for any reason, not able to undergo the 3D virtual planning procedure, including double dentition imprints/intra-oral scan, pre-operative CBCT scanning and virtual planning of translations. An example could be the inability to complete the dental imprint of both upper and lower jaw, or inadequate scanning of the patient. These examples will. If applicable, come up during the preparation appointment with the patient, and therefore do not delay the patient*s trajectory. • Patient has a cleft lip or cleft palate • Patient has a syndrome associated with craniofacial anomalies • The operation of the patient includes a multisegmental Le Fort 1 osteotomy of the maxilla
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is the geometrical change on dentition level. The baseline is the planned position, compared with the post-operative final position determined from CBCT. CBCT*s of the maxillofacial region will be made according to care as usual in our clinic; pre-operative, 1-wk post-operative, 1-yr post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.v.t. | — |
Countries
Netherlands
Outcome results
None listed